Phase 2
Completed N=160
Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
Source: ClinicalTrials.gov NCT01603277 ↗Enrolled (actual)
160
Serious AEs
4.4%
Results posted
Feb 2015
Primary outcomePrimary: Change in Percent Predicted FEV1 at Week 24 — 3.631; 2.000 Percent
Summary
This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent Predicted FEV1 at Week 24 |
3.631; 2.000 | — |
| SECONDARY To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate |
— | — |
| SECONDARY To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF) |
— | — |
| SECONDARY To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments |
— | — |
Eligibility Criteria
Key Inclusion Criteria
- A diagnosis of asthma established for at least 2 years
- Symptomatic asthma as defined by the Juniper Asthma Control Questionnaire
- Symptomatic asthma despite stable treatment with inhaled corticosteroids fluticasone or budesonide, or other corticosteroids, for at least 12 weeks
- Currently receiving inhaled long-acting beta agonist (LABA) or previously documented LABA intolerability or lack of responsiveness
- At least 2 exacerbations (no more than 6) in the previous 12 months that required systemic corticosteroids or at least a doubling of daily oral dose
Key Exclusion Criteria
- Acute asthma worsening (requiring emergency room visit, hospitalization, urgent care, physician visit, or change in asthma medications) or lower respiratory tract infection requiring the use of antibiotics, within 4 weeks prior to Screening Visit.
- History of life-threatening asthma with admission to the intensive care unit requiring the use of mechanical ventilation within the past 12 months
- Use of any immunosuppressive or immunomodulatory agents within 12 weeks or an investigational agent within 4 weeks prior to Screening Visit
- History of any cardiovascular, neurological, hepatic, or renal condition
- History of smoking within the past 12 months
Data sourced from ClinicalTrials.gov (NCT01603277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.